[Posted 01/13/2011] ISSUE: FDA notified healthcare professionals that it has asked drug manufacturers to limit the strength of acetaminophen in prescription drug products, predominantly combinations of acetaminophen and opioids, to 325 mg per tablet, capsule, or other dosage unit, making these products safer for patients. This action will help to reduce the risk of severe liver injury and allergic reactions associated with acetaminophen. A Boxed Warning highlighting the potential for severe liver injury and a Warning highlighting the potential for allergic reactions (swelling of the face, mouth, and throat, difficulty breathing, itching, or rash) will be added to the label of all prescription drug products that contain acetaminophen.

BACKGROUND: Acetaminophen, one of the most commonly used drugs in the United States, is widely and effectively used in both prescription and over-the-counter (OTC) products to reduce pain and fever. Examples of prescription products that contain acetaminophen include hydrocodone with acetaminophen (Vicodin, Lortab), and oxycodone with acetaminophen (Tylox, Percocet). OTC products containing acetaminophen (e.g., Tylenol) are not affected by this action. Information about the potential for liver injury is already required on the label for OTC products containing acetaminophen. FDA is continuing to evaluate ways to reduce the risk of acetaminophen related liver injury from OTC products. No drug shortages are expected, because the 3-year implementation period should permit adequate time for necessary reformulations.

RECOMMENDATION: Healthcare professionals were reminded to advise patients not to exceed the acetaminophen maximum total daily dose (4 grams/day), and not to drink alcohol while taking acetaminophen-containing medications.

Healthcare professionals were encouraged to inform patients that there is no immediate danger to patients who take these combination pain medications, and patients should continue to take them as directed by their health care provider. The Drug Safety Communication provides additional information for healthcare professionals, information for patients, a data summary and a list of all affected products. For more information visit the FDA website at: [Web] and [Web].

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What is this medicine?

DIPHENHYDRAMINE (dye fen HYE dra meen) is an antihistamine. This medicine is used to treat occasional sleeplessness.

What should I tell my health care provider before I take this medicine?

How should I use this medicine?

Take this medicine by mouth. Follow the directions on the label. Leave the tablet in the sealed blister pack until you are ready to take it. With dry hands, open the blister and gently remove the tablet. If the tablet breaks or crumbles, throw it away and take a new tablet out of the blister pack. Place the tablet in the mouth and allow it to dissolve, and then swallow. While you may take these tablets with water, it is not necessary to do so. Do not take your medicine more often than directed.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 12 years old for selected conditions, precautions do apply.

Patients over 65 years old may have a stronger reaction and may need a smaller dose.

Overdosage: If you think you've taken too much of this medicine contact a poison control center or emergency room at once.

What if I miss a dose?

This does not apply; this medicine is not for regular use. Do not take double or extra doses.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

-MAOIs like Carbex, Eldepryl, Marplan, Nardil, and Parnate
-other medicines that contain diphenhydramine
This medicine may also interact with the following medications:

What should I watch for while using this medicine?

Tell your doctor or health care professional if your symptoms do not start to get better or if they get worse. See your doctor if you have trouble sleeping every night for more than 2 weeks.

Your mouth may get dry. Chewing sugarless gum or sucking hard candy, and drinking plenty of water may help. Contact your doctor if the problem does not go away or is severe.

This medicine may cause dry eyes and blurred vision. If you wear contact lenses you may feel some discomfort. Lubricating drops may help. See your eye doctor if the problem does not go away or is severe.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol may interfere with the effect of this medicine. Avoid alcoholic drinks.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

-allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
-changes in vision
-confusion
-fast, irregular heartbeat
-irritable
-tremors
-trouble passing urine or change in the amount of urine
-unusual bleeding or bruising
-unusually weak or tired
Side effects that usually do not require medical attention (Report these to your doctor or health care professional if they continue or are bothersome.):

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